MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2015-120
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a 70% stenosed and tortuous lesion in the distal posterior tibial artery.Resistance was felt when advancing a 1.5x120mm armada 14 balloon catheter and the balloon ruptured during the first inflation.The procedure was successfully completed with a new 1.5x120mm armada 14 balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional analysis was performed on the returned device.The reported balloon rupture was not confirmed; however, a leak was confirmed.The difficulty advancing could not be confirmed as it was based on case circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.A cine was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the location of the noted resistance is unknown.However, it is visualized that there are several stents proximal and lesion calcification that could be contributing factors with this event.Based on the information provided, a conclusive cause for the difficulties could not be determined.It may be possible that the resistance encountered during advancement was the result of interaction with the previously implanted stents and/or lesion calcification.Additionally, it may be possible that while attempting to position the balloon within the lesion against resistance, stress may have been applied to the outer member causing displacement within the sidearm resulting in loss of pressure and ultimately leaking, as observed on the returned unit.However, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9477714
• Report Number: 2024168-2019-14606
• Device Sequence Number: 2306282
• Product Code: DQY
• UDI-Device Identifier: 08717648155932
• UDI-Public: 08717648155932
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: A2015-120
• Device Catalogue Number: A2015-120
• Device Lot Number: 9032041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 45